BEUDAMED
    FDA Recall Terminated

    Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

    Recall: Z-1277-2015 · Initiated October 10, 2014

    Recall

    Recall Number
    Z-1277-2015
    Event Number
    70143
    Firm
    US Infusion Inc dba Trucare Biomedix-USA
    FEI Number
    3008782867
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 10, 2014
    Posted
    March 13, 2015
    Terminated
    June 23, 2015
    Address
    6356 Manor Ln, Suite 103, South Miami, FL, 33143-4960

    Description

    Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

    Reason

    Several complaints regarding the IV sets leaking at the Y site.

    Action

    On December 10, 2014 the firm sent an URGENT DRUG RECALL to its consignees. Instructions were to immediately examine inventory and quarantine all product subject to the recall. Customers were asked to complete and return the response form. For returned goods instructions contact Roberta Parness at 866-593-8444 or via email at [email protected].

    Distribution

    Distributed in the states of TX, IL, MA, OH, CA, and GA.

    Quantity

    62,700 IV sets